Yoga on QOL Physiological Distress&Fatigue, on Patients Affected by Breast Cancer in Adjuvant Radiotherapy (YogaRT)
Primary Purpose
Female Breast Cancer, Fatigue, Quality of Life
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Yoga lessons
Sponsored by
About this trial
This is an interventional supportive care trial for Female Breast Cancer focused on measuring Female Breast Cancer, Fatigue, Quality of Life, Physiological Stress, Radiotherapy; Complications
Eligibility Criteria
Inclusion Criteria:
- Women with stage 0-III breast cancer who have undergone adjuvant daily radiotherapy for 5 weeks in Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (IRST) Department of Radiation Oncology of Meldola.
Exclusion Criteria:
- Patients with documented diagnosis of mental disorders (eg Schizophrenia)
- Patients with stage IV disease
- Patients with active or non-canalised deep vein thrombosis
- Patients not undergoing surgery for the basic oncological disease
- Patients with mobility problems (eg unable to get up from the chair)
- Patients who have practiced yoga or are practicing yoga in the 6 months before the cancer diagnosis.
- Patients diagnosed with lymphedema
Sites / Locations
- IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST s.r.l.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm Yoga (YG)
Arm control (CG)
Arm Description
Patients assigned to the YG arm participate in yoga classes
Patients assigned to the CG arm will follow the normal course of radiotherapy.
Outcomes
Primary Outcome Measures
Change of physiological distress
Evaluation of the efficacy of yoga on reduction of physiological distress after the end of radiotherapy, measured via Short Form 36 (SF-36), Pittsburgh Sleep Quality Index (PSQI) and Quality of life questionnaire Core30 (QLQ-C30) questionnaire, and physiological functions (cortisol, blood sampling with proinflammatory markers evaluation) in stage 0-III breast cancer patients
Secondary Outcome Measures
Evaluation of quality of life with yoga during and after radiotherapy
Assess whether yoga helps on increase Quality of Life (QOL) and decreasing fatigue via questionnaire Brief Fatigue Inventory (BFI).
Full Information
NCT ID
NCT04775290
First Posted
December 14, 2020
Last Updated
February 25, 2021
Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
1. Study Identification
Unique Protocol Identification Number
NCT04775290
Brief Title
Yoga on QOL Physiological Distress&Fatigue, on Patients Affected by Breast Cancer in Adjuvant Radiotherapy
Acronym
YogaRT
Official Title
Monocentric, Randomized Clinical Trial About the Effect of Yoga Practice on QOL, Physiological Distress and Fatigue, on Patients Affected by Breast Cancer Undergoing Adjuvant Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
April 4, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to investigate, through serial measurements of some biomarkers, the potential mechanisms through which yoga impacts on QOL and fatigue.
Detailed Description
The study aims to assess QoL, fatigue and physiological distress (cortisol and proinflammatory markers) with blood sampling on day 1,15 and last of radiotherapy, at 1-3-6 months after the end of radiotherapy.
Patients with breast cancer who will undergo radiotherapy will be randomly assigned to the yoga group (YG) or the control group (CG).
Patients in the YG will participate in 2 weekly yoga classes during the 5 weeks of radiation therapy. The classes will be coordinated with the treatment program and will be held in the vicinity of the radiation therapy center.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Breast Cancer, Fatigue, Quality of Life, Physiological Stress, Radiotherapy; Complications
Keywords
Female Breast Cancer, Fatigue, Quality of Life, Physiological Stress, Radiotherapy; Complications
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm Yoga (YG)
Arm Type
Experimental
Arm Description
Patients assigned to the YG arm participate in yoga classes
Arm Title
Arm control (CG)
Arm Type
No Intervention
Arm Description
Patients assigned to the CG arm will follow the normal course of radiotherapy.
Intervention Type
Behavioral
Intervention Name(s)
Yoga lessons
Intervention Description
2 weekly yoga classes during the 5 weeks of radiotherapy
Primary Outcome Measure Information:
Title
Change of physiological distress
Description
Evaluation of the efficacy of yoga on reduction of physiological distress after the end of radiotherapy, measured via Short Form 36 (SF-36), Pittsburgh Sleep Quality Index (PSQI) and Quality of life questionnaire Core30 (QLQ-C30) questionnaire, and physiological functions (cortisol, blood sampling with proinflammatory markers evaluation) in stage 0-III breast cancer patients
Time Frame
up to 32 months
Secondary Outcome Measure Information:
Title
Evaluation of quality of life with yoga during and after radiotherapy
Description
Assess whether yoga helps on increase Quality of Life (QOL) and decreasing fatigue via questionnaire Brief Fatigue Inventory (BFI).
Time Frame
up to 6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with stage 0-III breast cancer who have undergone adjuvant daily radiotherapy for 5 weeks in Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (IRST) Department of Radiation Oncology of Meldola.
Exclusion Criteria:
Patients with documented diagnosis of mental disorders (eg Schizophrenia)
Patients with stage IV disease
Patients with active or non-canalised deep vein thrombosis
Patients not undergoing surgery for the basic oncological disease
Patients with mobility problems (eg unable to get up from the chair)
Patients who have practiced yoga or are practicing yoga in the 6 months before the cancer diagnosis.
Patients diagnosed with lymphedema
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simona Micheletti, MD
Organizational Affiliation
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST s.r.l.
City
Meldola
State/Province
Forlì-Cesena
ZIP/Postal Code
47014
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Yoga on QOL Physiological Distress&Fatigue, on Patients Affected by Breast Cancer in Adjuvant Radiotherapy
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